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Lemmiwinks

03/30/20 9:59 PM

#258348 RE: Dancing in the dark #258344

I thought it was Mori 2010.

pax33

03/30/20 10:20 PM

#258373 RE: Dancing in the dark #258344

That looks like the right article. I understand I may be bias, but as a physician who reads a lot of different clinical studies this does NOT constitute enough evidence for obviousness. It is small (n=50s), ONLY included MEN, did NOT exclusively target >500 Trig (marine label), and patients had a fixed BMI between 25-30. It also had no mention of EPA lowering LDL (one of Vascepa's patents under contention I believe). My interpretation of "obviousness" is can a company submit this study to the FDA and expect them to give approval for that indication and will doctors read the study and feel keen to prescribe the drug for that indication. The answer is a resounding NO on both accounts. There are many studies of other drugs w/ small trials and with the number of patients in 50s that would at most raise an eyebrow and prompt additional larger studies. The reason is results from singular, small, and very focused studies are often contradicted by other small, focused studies. This literally happens all the time. I think in appeal this can easily be shown and demonstrated.

ggwpq

03/30/20 10:20 PM

#258374 RE: Dancing in the dark #258344

Thanks for posting. The highest baseline TG for the 59 patients were 234.71 mg/dL. I don't see any TG>500 patients.

For triglycerides in mg/dL, multiply mmol/L by 88.57

Whalatane

03/31/20 4:06 PM

#259094 RE: Dancing in the dark #258344

Dancing. thx for posting that link .
I had been thinking of Japanese studies where I thought researchers named Mori , had been cited. ....specifically regarding DHA affect on LDL levels. ...but have been unable to locate them .
My apologies .
Is this the one case that directed Judge Du's opinion ?
Kiwi